An exploration of factors influencing the selection of generic and innovator medicines in Saudi Arabia using an observational cross-sectional study.

Background and objectives: Generic medications are cost-effective without compromising therapeutic outcomes. Therefore, the goal of this study was to investigate, using a cross-sectional study design, the factors influencing Saudi Arabian consumers' preferences between innovator and generic medications. Methods: This cross-sectional study was carried out in Saudi Arabia using a Google survey form. For data collection, a simple random sampling strategy was used. The recruited participants were surveyed using a validated questionnaire that focused on six influencing domains: physician, pharmacist, perceived effectiveness, price, information availability, and confidence based on prior experience. The obtained data was used to analyze factors that have an association with any of the six domains using multinomial regression analysis. A correlation analysis was performed to examine the relationship between domains. Results: The 317 participants included 64.4 % females, 52 % aged ≥ 26, and a large proportion of Saudi nationals (82.6 %) and university graduates (78.9 %). Being employed (OR:3.029; P = 0.006; CI: 6.715-1.366), a healthcare providers (OR:2.298; P = 0.043; CI: 5.151-1.025), and having insurance coverage (OR:1.908; P = 0.017; CI: 3.245-1.122) had a greater influence on medication selection. Participants with linguistic and business educational backgrounds (OR:3.443; P = 0.022; CI: 9.950-1.191), those living in the northern region of Saudi Arabia (OR:3.174; P = 0.009; CI: 7.585-1.328), having chronic ailments (OR:3.863; P = 0.013; CI: 11.274-1.324), and possess insurance (OR:1.748; P = 0.039; CI: 2.971-1.028) get readily influenced by pharmacist. People who were married and lived in Saudi Arabia's southern region were influenced by perceived effectiveness when choosing medicine. Participants from the northern region were found to be influenced by the price of the medicines, information about the medicines, and confidence based on previous experience. The price of medicines has a significant impact on those suffering from chronic diseases. At a significant level of P = 0.01, all six influencing domains were found to be positively correlated with each other. Conclusion: The study shows that healthcare providers, drug prices, perceived efficacy, and information availability all have a big influence on the Saudi Arabian population's choice of medications. Educational background, location, and chronic disease status are associated with several influencing domains. Aside from public awareness campaigns, healthcare professionals should be involved in the implementation of the generic medication policy.

The impact of child-specific characteristics on warfarin dosing requirements.

Background: The influence of child characteristics on warfarin dosing has been reported; however, there is no consensus on the nature and extent of this effect. Objectives: To investigate the impacts of the demographic and clinical characteristics of children on the warfarin dose required to achieve a therapeutic international normalization ratio (INR). Methods: This retrospective cohort study included children aged 3 months to 14 years old who were prescribed warfarin for 3 months or longer with a "stable INR." The primary outcome was the total daily dose (TDD) and total weekly dose of warfarin required to achieve a therapeutic INR target. Results: We included 127 patients with a mean age of 7.7 ± 3.7 years and a median weight of 22 (IQR, 16-33) kg. Of the sample, 55 patients (43.3%) required a TDD of ≤0.1 mg/kg. The TDD for children younger than 5 years, 5 to 10 years, and older than 10 years were 0.14 ± 0.06 mg/kg, 0.12 ± 0.05 mg/kg, and 0.096 ± 0.04 mg/kg, respectively (P = .002). Overweight and obese children required a smaller TDD than normal-weight children: 0.09 ± 0.05 vs 0.13 ± 0.05 mg/kg (P = .004), which was similar for underweight children. A lower body surface area (<0.5 m2) required a higher dose. All the other variables did not affect warfarin doses. The incidence of a subtherapeutic or supratherapeutic INR was independent of demographic or clinical variables. Conclusion: The study confirmed that the patient demographics affect the daily warfarin dose required to achieve the INR target. However, they do not have any predictive value for the incidence of out-of-range-INR.

Fasting during Ramadan and acute kidney injury (AKI): a retrospective, propensity matched cohort study.

BACKGROUND: During the month of Ramadan, Muslims abstain from daytime consumption of fluids and foods, although some high-risk individuals are exempt. Because fasting's effects on the risk of acute kidney injury (AKI) have not been established, this study assesses the relationship between fasting and risk of AKI and identifies patients at high risk. METHODS: A single-center, retrospective, propensity-score matched, cohort study was conducted with data collected from adult patients admitted to the emergency room during Ramadan and the following month over two consecutive years (2016 and 2017). AKI was diagnosed based on the 2012 definition from the Kidney Disease: Improving Global Outcomes clinical practice guideline. Multivariable logistic regression analyses were used to examine the correlation and measure the effect of fasting on the incidence of AKI, and assess the effect of different variables on the incidence of AKI between the matching cohorts. RESULTS: A total of 1199 patients were included; after matching, each cohort had 499 patients. In the fasting cohort, the incidence of AKI and the risk of developing AKI were significantly lower (adjusted odds ratio (AOR) 0.65;95% confidence interval (CI) 0.44-0.98). The most indicative risk factors for AKI were hypertension (AOR 2.17; 95% CI 1.48-3.18), history of AKI (AOR 5.05; 95% CI 3.46-7.39), and liver cirrhosis (AOR 3.01; 95% CI 1.04-8.70). Patients with these factors or most other comorbidities in the fasting cohort had a lower risk of AKI as compared with their nonfasting counterparts. CONCLUSION: The data show a strong reduction in the risk of developing AKI as a benefit of fasting, particularly in patients with comorbid conditions. Therefore, most patients with comorbid conditions are not harmed from fasting during Ramadan. However, larger prospective studies are needed to investigate the benefit of fasting in reducing the risk of developing AKI.

The potential role of adjunctive ascorbic acid in the prevention of colistin-induced nephrotoxicity in critically ill patients: A retrospective study.

Background: Colistin is considered a valuable and last-resort therapeutic option for MDR gram-negative bacteria. Nephrotoxicity is the most clinically pertinent adverse effect of colistin. Vivo studies suggest that administering oxidative stress-reducing agents, such as ascorbic acid, is a promising strategy to overcome colistin-induced nephrotoxicity (CIN). However, limited clinical data explores the potential benefit of adjunctive ascorbic acid therapy for preventing CIN. Therefore, this study aims to assess the potential nephroprotective role of ascorbic acid as adjunctive therapy against CIN in critically ill patients. Method: This was a retrospective cohort study at King Abdulaziz Medical City (KAMC) for all critically ill adult patients who received IV colistin. Eligible patients were classified into two groups based on the ascorbic acid use as concomitant therapy within three days of colistin initiation. The primary outcome was CIN odds after colistin initiation, while the secondary outcomes were 30-day mortality, in-hospital mortality, ICU, and hospital LOS. Propensity score (PS) matching was used (1:1 ratio) based on the patient's age, SOFA score, and serum creatinine. Results: A total of 451 patients were screened for eligibility; 90 patients were included after propensity score matching based on the selected criteria. The odds of developing CIN after colistin initiation were similar between patients who received ascorbic acid (AA) as adjunctive therapy compared to patients who did not (OR (95 %CI): 0.83 (0.33, 2.10), p-value = 0.68). In addition, the 30-day mortality, in-hospital mortality, ICU, and hospital LOS were similar between the two groups. Conclusion: Adjunctive use of Ascorbic acid during colistin therapy was not associated with lower odds of CIN. Further studies with a larger sample size are required to confirm these findings.

Validity and reliability of the Arabic-translated kidney disease quality of life survey among long-term dialysis patients in Saudi Arabia.

One of the tools used to measure the quality of life in hemodialysis (HD) patients is the Kidney Disease Quality of Life (KDQOL) survey. The KDQOL has been through several developmental processes, with the most recent one being the KDQOL-36™. Our study evaluated the validity and reliability of the Arabic-translated KDQOL-36™ survey in Saudi chronic dialysis patients. This cross-sectional study was conducted at four HD centers in Saudi Arabia. The KDQOL-36™ survey was translated into Arabic according to the RAND Corporation's basic guidelines for translating surveys. The validation process was achieved by assessing reliability and validity. The reliability of the translated survey was established by Cronbach's alpha to measure internal consistency and the intra-class correlation coefficient (ICC) to measure the test-retest reliability. The validity of the translated survey was established based on content validity and convergent validity. The study included 184 patients (36-65 years; 60.9% of men). Regarding reliability, Cronbach's alpha for the subscales ranged from 0.63 to 0.89, and ICCs ranged from 0.60 to 0.88. For content validity, an expert panel reviewed the questions in depth. In addition, we found a positive relationship between all sub- and overall health-rated scores (P <0.01). The Arabic-translated version of the KDQOL-36™ survey is reliable and valid for evaluating the quality of life in Saudi chronic dialysis patients.

The Utilization of Spironolactone in Heart Failure Patients at a Tertiary Hospital in Saudi Arabia.

INTRODUCTION: Heart failure (HF) has high morbidity and mortality rates. Spironolactone has shown a 30% reduction in all-cause mortality, reduction in hospitalizations, and sudden death. However, data shows low use of spironolactone in HF patients. We aim to assess spironolactone utilization in HF reduced Ejection Fraction (HFrEF) patients and to identify the factors affecting its prescribing. METHODS: A retrospective cross-sectional study of patients diagnosed with HF from January 2016 to January 2017 conducted at King Abdulaziz Medical City-Riyadh. INCLUSION CRITERIA: all adult HFrEF <40% who are eligible for spironolactone with New York Heart Association (NYHA) class II-IV. Serum creatinine should be <2.5 mg/dL in men or <2.0 mg/dL in women, or estimated glomerular filtration rate (eGFR) >30 mL/min/1.73m2 and potassium <5.0 mEq/L. EXCLUSION CRITERIA: pediatrics, end-stage renal disease, primary aldosteronism, and allergy to spironolactone. RESULTS: We screened around 5000 HF patients, of whom 368 were included. Among 195 patients who were not on spironolactone, 121 patients were eligible to use it; however, they did not receive it. One hundred seventy-three patients were on spironolactone, of whom 30 received the drug although they did not meet the eligibility criteria. The mean age of patients on spironolactone was 61±14 and the mean age of patients not on spironolactone was 66.6±15.6. Two hundred seventy-seven patients in the study population were male. Regarding comorbidities, 265 patients were diabetic. As for laboratory findings, the mean potassium for patients on spironolactone was 4.3 mEq/L; the creatinine and eGFR for patients on spironolactone were 82 umol/L (0.9 mg/dl) and 88 mL/min/1.73m2 while those not on spironolactone had higher creatinine at 93 umol/L (1 mg/dl) and eGFR 80 mL/min/1.73m2. Using multivariate regression, we found many factors affecting spironolactone utilization, including EF before spironolactone, serum creatinine, angiotensin-converting enzyme inhibitors (ACEI), angiotensin-II receptor antagonists (ARBs), furosemide, statin, and stroke. CONCLUSIONS: Spironolactone for HFrEF is underutilized. EF before spironolactone, serum creatinine, ACEI, ARBs, furosemide, statin, and stroke significantly affect spironolactone utilization. Further studies are warranted to identify barriers affecting spironolactone utilization in HF patients from prescribers' perspectives.

Awareness of acute kidney injury risk factors and perspectives on its practice guidelines.

OBJECTIVES: Identifying and assessing risk factors for acute kidney injury (AKI) are crucial for its early detection and possible intervention to prevent AKI and associated adverse outcomes. This study aimed to investigate AKI risk factor awareness and risk assessment by healthcare professionals and to evaluate perspectives on the Kidney Disease Improving Global Outcomes AKI guidelines. METHODS: This cross-sectional survey-based study was conducted among healthcare professionals (physicians and pharmacists) at XXX from December 2016 to February 2017. RESULTS: Among the respondents (117 physicians and 135 pharmacists), 78% were aged ≤38 years, 57% were men, and 70% had <9 years of experience. Respondents varied in their knowledge of the 25 risk factors for AKI and 15 nephrotoxic drugs: 96% were aware of nephrotoxic medication, whereas 20% acknowledged female sex as an AKI risk factor, and 92% agreed with aminoglycoside, while 47% agreed with ciprofloxacin as nephrotoxic drugs. A significantly higher percentage of physicians identified individual AKI risk factors than pharmacists; however, a significantly higher percentage of pharmacists identified individual AKI-causing drugs than physicians. Although 77% of respondents encountered AKI cases in their practice, only half of them performed AKI risk assessment, and 42% stratified patients' AKI risk according to their presenting risk factors or documented AKI in previous medical history. Seventy-one percent of respondents agreed that practice guidelines improve patient outcome, and 69% thought these guidelines help standardize care and ensure that patients are treated in consistently. CONCLUSION: While the majority of the respondents had a positive perspective toward AKI guidelines, a large variation in their knowledge of AKI risk factors, risk assessment, and nephrotoxic drugs was found. Educational efforts are needed to raise awareness and thereby reduce this variation.

Predictors of adherence to a new erythropoiesis-stimulating agent inpatient ordering policy: A cross-sectional study.

BACKGROUND: Erythropoiesis-stimulating agents (ESAs) are recommended for treating anemia in patients with chronic kidney disease and end-stage renal disease. However, misappropriate and over-use of these agents can be costly and unnecessary in some settings. OBJECTIVE: The primary aim was to identify predictors of adherence to a newly approved ESA inpatient ordering policy. The secondary aims were to evaluate the impact of a 5-day delay in the initiation of ESA therapy on ESA usage, hemoglobin (Hb) levels, and costs. METHODS: This retrospective observational record review included a sample of adult patients admitted to four tertiary care hospitals from November 1, 2013 to August 31, 2014. Multivariable logistic and linear regression analyses were used to calculate the odds of adherence to the new ESA inpatient ordering policy and the impact of this policy on discharge Hb level, respectively. RESULTS: A total of 242 patients were included. The majority of the prescribers (77%) adhered to the new ESA ordering policy. Hemoglobin (OR = 1.306; 95% CI: 1.03-1.65) and ferritin (OR = 3.91; 95% CI: 1.23-12.51) levels at admission and length of hospital stay were positively correlated with the odds of patients receiving ESAs after day 5 (OR = 1.12; 95% CI:1.05-1.20). Furthermore, adherence to the new policy did not have a significant impact on discharge Hb level (ß = 0.02349; P = 0.895). CONCLUSIONS: Prescribers were adherent to a 5-day delay in the initiation of ESA therapy policy which resulted in a reduction in ESA usage, did not impact the discharge Hb levels, and was proven to be cost effective.

Acute Kidney Injury in Patients Continued on Renin-Angiotensin System Blockers During Hospitalization.

BACKGROUND: Acute kidney injury (AKI) is common in hospitalized patients and is associated with adverse outcomes. This study aimed to evaluate patient characteristics and interventions during hospitalization associated with the development of AKI in patients continued on renin-angiotensin system (RAS) blockers during hospitalization. METHODS: A retrospective study of 184 adult patients admitted between January 2012 and September 2014 and continued on RAS blockers was conducted. Risk factors for AKI were compared between AKI (n = 92) and non-AKI (n = 92) groups. RESULTS: Patients who developed hospital-acquired AKI had a higher baseline serum creatinine (1.2 ± 0.4 versus 1 ± 0.3mg/dL, P < 0.001) and lower estimated glomerular filtration rate (54 ± 10 versus 57 ± 7mL/minute/1.73m2, P = 0.03) compared with patients who did not develop AKI. Patients who developed AKI were also more likely to be admitted to the intensive care unit, have surgical procedures, have hypotension and be prescribed loop diuretics. The presence of chronic kidney disease and hypotension were risk factors associated with AKI development. In addition, the AKI group had a significantly longer length of stay (14 days versus 8 days, P < 0.0001) and had a higher rate of all-cause hospital mortality (9% versus 1%, P = 0.03). CONCLUSIONS: Patients with chronic kidney disease, hypotension and those undergoing surgeries were more likely to develop AKI while receiving RAS blockers. During hospitalization, temporary discontinuation of these medications may be warranted in patients with these characteristics.

Evaluation of warfarin dose requirements in patients with chronic kidney disease and end-stage renal disease.

STUDY OBJECTIVES: The effect of chronic kidney disease (CKD) on warfarin has gained attention because of an increased risk of thromboembolism and an increased risk of bleeding associated with warfarin treatment in these patients. Data suggest that patients with reduced kidney function require lower warfarin doses; however, relatively few patients with end-stage renal disease (ESRD) were included in previous studies. The goal of this study was to evaluate warfarin dosing requirements and time to reach therapeutic international normalized ratio (INR) in patients with CKD stages 3-5 and ESRD compared with patients with normal kidney function (NKF). METHODS: A historical cohort was identified to evaluate warfarin response in 210 hospitalized adults with varying degrees of kidney function initiated or maintained on warfarin for 4 or more consecutive days including 49 patients with NKF (glomerular filtration rate [GFR] higher than 60 ml/min/1.73 m(2) ), 44 with CKD stage 3, 27 with CKD stage 4/5, and 90 with ESRD. The average daily dose (ADD), time to achieve a therapeutic INR, and adverse effects were compared. MEASUREMENTS AND MAIN RESULTS: The ADD to maintain a therapeutic INR was 5.6 ± 1.7 mg in the NKF group, 4.3 ± 1.6 mg in CKD stage 3, 4.6 ± 1.9 mg in CKD stage 4/5, and 4.8 ± 1.9 mg in ESRD. The ADD was lower in CKD/ESRD patients compared with NKF patients (p=0.001), especially among whites. The time to reach a therapeutic INR in patients newly initiated on warfarin was significantly lower in the CKD/ESRD group when compared with the NKF group (p=0.02). No differences in bleeding episodes were observed during hospitalization or within 30 days of discharge in patients with CKD stage 3 or higher compared with patients with NKF. CONCLUSIONS: Our findings suggest that CKD and ESRD patients require ~20% lower warfarin doses to maintain a therapeutic INR and may require less time to achieve a therapeutic INR compared with patients with NKF.

Comparison of initial warfarin response in obese patients versus non-obese patients.

Achieving therapeutic anticoagulation with warfarin is complicated by substantial inter-patient and intra-patient variability with numerous factors known to influence dose requirements. Obesity is one factor for which there remains no study to date investigating its initial effect on warfarin response assessed by INR, stratified by BMI category in hospitalized patients. To compare initial warfarin response between obese and non-obese patients by evaluating average daily dose (ADD), time required to attain therapeutic INR, and mean discharge dose (MDD), stratified by BMI category. A retrospective review was conducted to evaluate initial warfarin response in hospitalized patients of different BMI categories initiated on warfarin with ≥4 consecutive days of therapy and managed by pharmacy dosing service. 211 patients were included (10 underweight, 45 normal weight, 48 overweight, 71 obese, 37 morbidly obese). Across BMI categories, the percentage of patients attaining therapeutic INR prior to discharge differed (p = 0.0004) with 71.1 % of normal weight therapeutic compared to 42.3 % of obese and 38 % of morbidly obese. Within BMI categories, when comparing ADD between patients therapeutic and subtherapeutic at discharge, no differences were observed, except among overweight patients (5.6 ± 0.3 vs. 7 ± 0.4 mg, p = 0.0143). Compared to normal weight, obese and morbidly obese required a significantly longer median time to achieve therapeutic INR (8 and 10 days vs. 6 days) and a higher ADD (6.6 ± 0.3 and 7.6 ± 0.5 vs. 5 ± 0.3 mg) and MDD (6.7 ± 0.5 and 6.7 ± 0.7 vs. 4.4 ± 0.5 mg). Compared to normal weight, obese and morbidly obese patients had a decreased initial response to warfarin.